HealthyPhase 3NCT02543567

A Study to Evaluate A Range of Dose Levels of Ad26.ZEBOV and MVA-BN-Filo in Healthy Adult Participants

A Phase 3 study testing Ad26.ZEBOV 5*10^10 viral particles (vp), Ad26.ZEBOV 2*10^10 (vp) and Ad26.ZEBOV 0.8*10^10 (vp) in people with Healthy, run by Janssen Vaccines & Prevention B.V. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to demonstrate the non-inferiority of a heterologous prime-boost regimen using Ad26.ZEBOV as prime and MVA-BN-Filo as boost administered at different doses at a 56-day interval versus the same regimen with the recently released batches of Ad26.ZEBOV and MVA-BN-Filo in terms of humoral… Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Ad26.ZEBOV 5*10^10 viral particles (vp), Ad26.ZEBOV 2*10^10 (vp) and Ad26.ZEBOV 0.8*10^10 (vp)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 525 participants
Where: 6 sitesUnited States
Study dates: 21 Sep 2015to 29 Nov 2016
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Must be healthy in the Investigator's clinical judgment on the basis of medical history, physical examination, electrocardiogram (ECG) and vital signs performed at Screening
Must be healthy on the basis of clinical laboratory tests performed at Screening
Before randomization, a woman must be either of childbearing potential and practicing (or intending to practice) a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for participants participating in clinical studies, beginning at least 28 days prior to vaccination OR not of childbearing potential: postmenopausal [greater than (>)] 45 years of age with amenorrhea for at least 2 years or any age with amenorrhea for at least 6 months, and a serum follicle stimulating hormone (FSH) level >40 international unit per milliliter (IU/L); permanently sterilized (for example, bilateral tubal occlusion [which includes tubal ligation procedures as consistent with local regulations], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy
Woman of childbearing potential must have a negative serum [beta-human chorionic gonadotropin (beta-hCG)] at Screening and a negative urine beta-hCG pregnancy test immediately prior to each study vaccine administration
Man who is sexually active with a woman of childbearing potential and has not had a vasectomy performed more than 1 year prior to Screening must be willing to use condoms for sexual intercourse beginning prior to enrollment, in addition to the birth control method used by the female partner

Who cannot join

Having received a candidate Ebola vaccine
Diagnosed with Ebola virus disease, or prior exposure to Ebola virus, including travel to West Africa less than 1 month prior to Screening. West Africa includes but is not limited to the countries of Guinea, Liberia, Mali, and Sierra Leone
Having received any experimental candidate adenovirus serotype 26 (vector: Ad26) or Modified Vaccinia Ankara (MVA)- based vaccine in the past
Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the study vaccines) including known allergy to egg, egg products and aminoglycosides
Presence of acute illness or temperature greater than or equal to (>=) 38.0 (°C) centigrade on Day 1

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Study site
Huntsville, Alabama
Study site
Melbourne, Florida
Study site
Mishawaka, Indiana
Study site
Peoria, Illinois
Study site
Rockville, Maryland
Study site
San Diego, California

Other trials in United States

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate A Range of Dose Levels of a Heterologous Prime-Boost Regimen of Ad26.ZEBOV and MVA-BN®-Filo in Healthy Adult Subjects

Read the detailed description

This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate safety and immunogenicity of Ad26.ZEBOV and MVA-BN-Filo at different dose levels, administered to healthy adults participants. The study consists of a Screening period of up to 6 weeks, vaccinations on Day 1 and Day 57, and a post-vaccination phase until the 6 months post-boost visit (Day 237). The participants will be randomized at baseline (on Day 1) in a 2:2:2:1 ratio to Groups 1, 2, 3 and 4. Safety will be monitored throughout the study.

Conditions: Healthy
Being tested: Ad26.ZEBOV 5*10^10 viral particles (vp), Ad26.ZEBOV 2*10^10 (vp), Ad26.ZEBOV 0.8*10^10 (vp), MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.], MVA-BN-Filo 5*10^7 Inf. U.
Keywords: Ebola viruses, Ebola virus disease (EVD), Filoviruses, Monovalent vaccine, Safety, Immunogenicity, Ebola vaccine, Human adenovirus serotype 26 (Ad26) expressing the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV), Modified Vaccinia Virus Ankara - Bavarian Nordic Filo-vector (MVA-BN Filo), Healthy participants
Medical subject headings: Hemorrhagic Fever, Ebola

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ad26.ZEBOV 5*10^10 viral particles (vp)Biological
Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 5*10^10 viral particles on Day 1
Ad26.ZEBOV 2*10^10 (vp)Biological
Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 2*10^10 viral particles on Day 1
Ad26.ZEBOV 0.8*10^10 (vp)Biological
Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 0.8*10^10 viral particles on Day 1
MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.]Biological
MVA-BN-Filo- live replication incompetent vaccine, IM injection of 1*10^8 Infectious Unit [Inf. U.] once on Day 57
MVA-BN-Filo 5*10^7 Inf. U.Biological
MVA-BN-Filo- live replication incompetent vaccine, IM injection of 5*10^7 Inf. U. once on Day 57
PlaceboBiological
One 0.5 ml IM injection of 0.9% saline administered once on Day 1 and Day 57

Study groups in NCT02543567
Study group	Role	What they receive
Group 1	Experimental	Ad26.ZEBOV 510^10 viral particles (vp) single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 110^8 Infectious Unit [Inf. U.] single dose IM injection on Day 57 Receives: Biological: Ad26.ZEBOV 510^10 viral particles (vp); Biological: MVA-BN-Filo 110^8 Infectious Unit [Inf. U.]
Group 2	Experimental	Ad26.ZEBOV 210^10 vp single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 510^7 Inf. U single dose IM injection on Day 57 Receives: Biological: Ad26.ZEBOV 210^10 (vp); Biological: MVA-BN-Filo 510^7 Inf. U.
Group 3	Experimental	Ad26.ZEBOV 0.810^10 vp single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 510^7 Inf. U. single dose IM injection on Day 57 Receives: Biological: Ad26.ZEBOV 0.810^10 (vp); Biological: MVA-BN-Filo 510^7 Inf. U.
Group 4	Experimental	Participants will receive intramuscular (IM) injection of Placebo (0.9% saline) once on Day 1 and Day 57 Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein Enzyme-linked Immunosorbent Assay (ELISA)
The humoral immune response will be assessed by enzyme-linked immunosorbent assay (ELISA) binding antibody
Measured: At 21 days post boost vaccination

Secondary outcomes (4)

Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein Enzyme-linked Immunosorbent Assay (ELISA)
The humoral immune response will be assessed by enzyme-linked immunosorbent assay (ELISA) binding antibody
Measured: At Days 1, 29, 57 post prime dose and at days 42, and 180 post boost vaccination
Number of Participants with Solicited Local and Systemic Adverse Events (AEs)
Measured: Up to 7 days after each vaccination
Number of Participants with Adverse Events (AEs)
Measured: Up to 42 days post boost vaccination
Number of Participants with Serious Adverse Events (SAEs)
Measured: Continuous throughout the duration of study (Up to Day 237)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Sep 201529 Nov 2016

First posted7 Sep 2015 (estimated)
Study start21 Sep 2015
Primary completion7 Jun 2016
Study completion29 Nov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 525 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02543567
Sponsor's protocol ID: CR107861
Other IDs: VAC52150EBL3002
Status last verified: May 2025
First submitted: 4 Sep 2015
Last updated: 25 May 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated device: No

Publications

Bockstal V, Gaddah A, Goldstein N, Shukarev G, Bart S, Luhn K, Robinson C, Anumendem D, Leyssen M, Douoguih M. Assessments of different batches and dose levels of a two-dose Ad26.ZEBOV and MVA-BN-Filo vaccine regimen. NPJ Vaccines. 2021 Dec 20;6(1):157. doi: 10.1038/s41541-021-00402-8.
PubMed 34930928

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate A Range of Dose Levels of a Heterologous Prime-Boost Regimen of Ad26.ZEBOV and MVA-BN®-Filo in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT02543567
Acronym / sponsor ID: CR107861
Conditions: Healthy
Keywords: Ebola viruses, Ebola virus disease (EVD), Filoviruses, Monovalent vaccine, Safety, Immunogenicity, Ebola vaccine, Human adenovirus serotype 26 (Ad26) expressing the Ebola virus Mayinga variant glycoprotein (Ad26.ZEBOV)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 525 participants (actual)
Lead sponsor: Janssen Vaccines & Prevention B.V.Industry (pharma, biotech, devices)
Study start: 21 Sep 2015 (actual)
Primary completion: 7 Jun 2016 (actual)
Study completion: 29 Nov 2016 (actual)
First posted: 7 Sep 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Group 1	Experimental	Biological: Ad26.ZEBOV 510^10 viral particles (vp), Biological: MVA-BN-Filo 110^8 Infectious Unit [Inf. U.]Ad26.ZEBOV 510^10 viral particles (vp) single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 110^8 Infectious Unit [Inf. U.] single dose IM injection on Day 57
Group 2	Experimental	Biological: Ad26.ZEBOV 210^10 (vp), Biological: MVA-BN-Filo 510^7 Inf. U.Ad26.ZEBOV 210^10 vp single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 510^7 Inf. U single dose IM injection on Day 57
Group 3	Experimental	Biological: Ad26.ZEBOV 0.810^10 (vp), Biological: MVA-BN-Filo 510^7 Inf. U.Ad26.ZEBOV 0.810^10 vp single dose intramuscular (IM) injection on Day 1; MVA-BN-Filo 510^7 Inf. U. single dose IM injection on Day 57
Group 4	Experimental	Biological: PlaceboParticipants will receive intramuscular (IM) injection of Placebo (0.9% saline) once on Day 1 and Day 57

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Must be healthy in the Investigator's clinical judgment on the basis of medical history, physical examination, electrocardiogram (ECG) and vital signs performed at Screening
Must be healthy on the basis of clinical laboratory tests performed at Screening
Before randomization, a woman must be either of childbearing potential and practicing (or intending to practice) a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for participants participating in clinical studies, beginning at least 28 days prior to vaccination OR not of childbearing potential: postmenopausal [greater than (>)] 45 years of age with amenorrhea for at least 2 years or any age with amenorrhea for at least 6 months, and a serum follicle stimulating hormone (FSH) level >40 international unit per milliliter (IU/L); permanently sterilized (for example, bilateral tubal occlusion [which includes tubal ligation procedures as consistent with local regulations], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy
Woman of childbearing potential must have a negative serum [beta-human chorionic gonadotropin (beta-hCG)] at Screening and a negative urine beta-hCG pregnancy test immediately prior to each study vaccine administration
Man who is sexually active with a woman of childbearing potential and has not had a vasectomy performed more than 1 year prior to Screening must be willing to use condoms for sexual intercourse beginning prior to enrollment, in addition to the birth control method used by the female partner

Key exclusion criteria (5 listed)

Having received a candidate Ebola vaccine
Diagnosed with Ebola virus disease, or prior exposure to Ebola virus, including travel to West Africa less than 1 month prior to Screening. West Africa includes but is not limited to the countries of Guinea, Liberia, Mali, and Sierra Leone
Having received any experimental candidate adenovirus serotype 26 (vector: Ad26) or Modified Vaccinia Ankara (MVA)- based vaccine in the past
Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the study vaccines) including known allergy to egg, egg products and aminoglycosides
Presence of acute illness or temperature greater than or equal to (>=) 38.0 (°C) centigrade on Day 1

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ad26.ZEBOV 510^10 viral particles (vp)Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 510^10 viral particles on Day 1	Biological	Group 1
Ad26.ZEBOV 210^10 (vp)Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 210^10 viral particles on Day 1	Biological	Group 2
Ad26.ZEBOV 0.810^10 (vp)Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 0.810^10 viral particles on Day 1	Biological	Group 3
MVA-BN-Filo 110^8 Infectious Unit [Inf. U.]MVA-BN-Filo- live replication incompetent vaccine, IM injection of 110^8 Infectious Unit [Inf. U.] once on Day 57	Biological	Group 1
MVA-BN-Filo 510^7 Inf. U.MVA-BN-Filo- live replication incompetent vaccine, IM injection of 510^7 Inf. U. once on Day 57	Biological	Group 2, Group 3
PlaceboOne 0.5 ml IM injection of 0.9% saline administered once on Day 1 and Day 57	Biological	Group 4

Primary outcome

Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein Enzyme-linked Immunosorbent Assay (ELISA)
Time frame: At 21 days post boost vaccination
The humoral immune response will be assessed by enzyme-linked immunosorbent assay (ELISA) binding antibody

4 secondary outcomes

Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein Enzyme-linked Immunosorbent Assay (ELISA)
Time frame: At Days 1, 29, 57 post prime dose and at days 42, and 180 post boost vaccination
Number of Participants with Solicited Local and Systemic Adverse Events (AEs)
Time frame: Up to 7 days after each vaccination
Number of Participants with Adverse Events (AEs)
Time frame: Up to 42 days post boost vaccination
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Continuous throughout the duration of study (Up to Day 237)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
Derived from this study: PubMed 34930928Bockstal V, Gaddah A, Goldstein N, Shukarev G, Bart S, Luhn K, Robinson C, Anumendem D, Leyssen M, Douoguih M. Assessments of different batches and dose levels of a two-dose Ad26.ZEBOV and MVA-BN-Filo vaccine regimen. NPJ Vaccines. 2021 Dec 20;6(1):157. doi: 10.1038/s41541-021-00402-8.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janssen Vaccines & Prevention B.V. Clinical Trial study director

Janssen Vaccines & Prevention B.V.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immune Responses to the Study Vaccine Regimens against Ebola virus (EBOV) Glycoprotein (GP) using EBOV GP protein Enzyme-linked Immunosorbent Assay (ELISA) (time frame: At 21 days post boost vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02543567, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.